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Results of study evaluating 52-week efficacy and safety of Skyrizi in psoriasis patients with a prior suboptimal response to IL-17 A inhibitor therapy.- AbbVie

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Published:19th Mar 2023

AbbVie announced new 52-week data from an open-label, single-arm study demonstrating improved plaque psoriasis signs and symptoms among a difficult-to-treat patient population who received Skyrizi (risankizumab), an IL-23 inhibitor.

These moderate to severe plaque psoriasis patients previously had a suboptimal response to treatment with secukinumab or ixekizumab, both IL-17A inhibitor therapies, for at least six months before switching to risankizumab. The data were presented at a Late-Breaking Research session during the 2023 American Academy of Dermatology (AAD) Annual Meeting in New Orleans, Louisiana.

Findings from this phase IIIb, open-label single-arm study showed that 56.3% of patients who received risankizumab, without a washout period following a suboptimal response to secukinumab or ixekizumab achieved the week 16 primary endpoint of reduced signs and symptoms of psoriasis (sPGA 0/1). A suboptimal response was defined as a static Physician's Global Assessment (sPGA) score of 2 or 3 and body surface area of 3% to greater than 10% after at least six months of treatment with secukinumab or ixekizumab. The mean duration of treatment was 2.6 years for patients receiving secukinumab, and 2.1 years for patients receiving ixekizumab.

Highlights from this new aIMM 52-week analysis include : i. The majority of patients (63.0%) achieved clear or almost clear skin (sPGA 0/1) at the week 52 primary endpoint. ii. Patients achieved completely clear skin (sPGA score of 0) at week 16 (19.8%) and week 52 (26.2%), a secondary endpoint. iii. Patients reported no symptoms such as pain, itching, redness and burning, as shown by a Psoriasis Symptom Scale (PSS) score of 0 at week 16 (20.2%) and week 52 (27.4%), a secondary endpoint. iv. No new safety signals were observed in this analysis.

"Advanced therapies represent an important option in the treatment of plaque psoriasis, but as a physician, it's critically important to continually assess if patients are having an optimal response to treatment, as residual psoriasis can still have a significant impact on a patient's life," said Professor Richard Warren from the University of Manchester and Norten Care Alliance, UK. This study showed that risankizumab was able to improve clinical signs and symptoms of patients who had a suboptimal response with the anti-IL-17 therapies secukinumab and ixekizumab, contributing to the whole of evidence supporting risankizumab use in moderate to severe plaque psoriasis."

About the Phase IIIb, Open-Label Study : The findings presented are part of a Phase IIIb, multicenter, interventional, open-label, single-arm study of adults ages 18 years or older with moderate to severe plaque psoriasis. The trial included 252 participants who had been treated with secukinumab or ixekizumab for at least six months and experienced a suboptimal response, defined as sPGA score of 2 or 3 and body surface area of 3% to less than 10%. Participants received Skyrizi 150mg at weeks 0, 4, and once every 12 weeks for 52 weeks without a washout period. The primary endpoint was the percentage of participants achieving an sPGA score of 0/1 at week 16. The secondary endpoints were sPGA 0/1 at week 52, and sPGA 0, DLQI 0/1 and PSS 0 at weeks 16 and 52. The mean duration of treatment was 2.6 years for patients receiving secukinumab and 2.1 years for ixekizumab-treated patients. This finding was previously reported at the European Academy of Dermatology and Venereology (EADV) 2022 Congress.

Efficacy results were assessed by non-responder imputation. Limitations of this analysis include lack of placebo control or active comparator; definition of suboptimal response has been based on expert feedback and to reflect clinical practice. Safety was monitored throughout the study.

Condition: Psoriasis
Type: drug

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